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. 2018 Dec;15(3):263-270.
doi: 10.4274/tjps.79553. Epub 2018 Nov 20.

Development of the Composition and Manufacturing Technology of a New Combined Drug: Lavaflam

Tanya Ivko  1 , Milena Aslanian  2 , Larisa Bobrytska  2 , Natalia Popova  2 , Olena Nazarova  3 , Natalia Bereznyakova  2 , Tamara Germanyuk  1
Affiliations

Development of the Composition and Manufacturing Technology of a New Combined Drug: Lavaflam

Tanya Ivko et al. Turk J Pharm Sci. 2018 Dec.

Abstract

Objectives: Treatment of diseaes of the biliary system is one of the urgent problems of modern medicine.

Materials and methods: An original pharmaceutical drug "Lavaflam" in the form of combined tablets, which includes a composition of herbal components flamin (0.05 g) and lavender oil (0.02 g), was proposed for the complex treatment of diseases of the biliary system. Flamin is phytomedicine from the immortelle flowers [Helichrysum arenarium (L.) Moench, Asteraceae], which contains a complex of active substances from the flavonoids group (salipurposide, isosalipurposide, kaempferol, luteolin). It is applied as a choleretic and an anti-inflammatory agent in cholecystitis, cholangitis, and biliary dyskinesia. Tablets were prepared by pressing for separate granulation technology.

Results: The lavender oil granulate was prepared using the solid phase method, and β-cyclodextrin was used as an excipient substance. The flamin granulate was prepared by mixing with the spherical-shaped filler mannitol PARTECK M 200. On the basis of previous studies, the excipients of the designed composition tablet "Lavaflam" were β-cyclodextrin (0.27 g), mannitol PARTECK M 200 (0.20 g), croscarmellose sodium (0.03 g), potato starch (0.022 g), PEG 6000 (0.002 g), and magnesium stearate (0.006 g). The assay of the main components of lavender oil with the references linalol and linalyl acetate was performed using gas chromatography. The assay of the total flavonoids of flamin was performed using spectrophotometry with isosalipurposide as the reference.

Conclusion: The new phytomedicine tablets "Lavaflam" meet European Pharmacopoeia requirements on the following parameters: appearance, geometric size, average weight, disintegration, friability, resistance of tablets to crushing, and quantification.

Keywords: Lavender oil; flamin; tablets Lavaflam.

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Conflict of interest statement

Conflict of Interest: No conflict of interest was declared by the authors.

Figures

Figure 1
Figure 1
Effect of β-cyclodextrin concentration on the stability lavender oil during storage
Figure 2
Figure 2
Study of stability lavender oil granulate with β-cyclodextrin at a temperature of (20±5)°C and (40±5)°C
Figure 3
Figure 3
Comparative chart of flowability for various excipients MCC: Microcrystalline cellulose
Figure 4
Figure 4
Effect of amount of fillers on flowability
Figure 5
Figure 5
Effect of disintegrants on tablet disintegration
See this image and copyright information in PMC

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